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Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence
Sponsor: UNICANCER
Summary
The standard treatment of localized breast cancers consists of surgical removal of the tumor at the breast or removal of the entire breast and lymph nodes (sentinel lymph node and / or axillary dissection) with or without chemotherapy followed by radiotherapy on the breast or thoracic wall and the lymph node areas from 5 to 6.5 weeks. Shorter radiotherapy treatments over 3 weeks for breast cancer without lymph node involvement have been equally effective and have no more side effects in several clinical trials involving several thousand patients. This called hypofractionated radiotherapy has become a standard for breast cancers in the absence of lymph node involvement in postmenopausal women. The objective of the HypoG01 trial is to evaluate hypofractionated radiotherapy in women who require radiotherapy in the breast or chest wall and lymph node areas by comparing standard over 5 to 6.5 weeks and hypofractionated irradiation over 3 weeks analyzing the possible side effects and in particular the risk of lymphedema (swelling of the arm on the side treated) and the effectiveness of these treatments
Official title: Multicenter Randomized Phase III Trial Comparing Hypofractionated Versus Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation in Terms of Lymphedema Occurrence
Key Details
Gender
FEMALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
1265
Start Date
2016-09
Completion Date
2030-09
Last Updated
2024-04-09
Healthy Volunteers
No
Conditions
Interventions
HYPOFRACTIONATED
40 Gy/ 15 fractions / 3 weeks
NORMOFRACTIONATED
50 Gy/ 25 fractions / 5 weeks
Locations (28)
Clinique de l'Europe
Amiens, France
Institut de Cancerologie de L'Ouest-Paul Papin
Angers, France
Hôpital Jean Minjoz
Besançon, France
Institut Bergonie
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Hoptal Henri Mondor
Créteil, France
Centre Georges Francois Leclerc
Dijon, France
Centre Guillaume Le Conquerant
Le Havre, France
Centre de radiothérapie Hartmann
Levallois-Perret, France
Centre Galilée - Hôpital Privé La Louvière
Lille, France
Centre Oscar Lambret
Lille, France
Clinique Chenieux
Limoges, France
Hôpital du Scorff
Lorient, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
ICM Val d'Aurelle
Montpellier, France
Institut de Cancerologie de Lorraine
Nancy, France
Centre Antoine Lacassagne
Nice, France
Hopital Saint-Louis
Paris, France
Institut Curie
Paris, France
Centre Eugene Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Institut Curie- Rene Huguenin
Saint-Cloud, France
Institut de Cancerologie de L'Ouest-Rene Gauducheau
Saint-Herblain, France
Centre Paul Strauss
Strasbourg, France
Institut Claudius Regaud
Toulouse, France
CHU Bretonneau
Tours, France
Gustave Roussy
Villejuif, France